Targeted Biopsy 'Better at Detecting High-Risk Prostate Cancers than Standard Biopsy'

“If results of a prostate-specific antigen test or digital rectal exam are positive, the next port of call is normally a prostate biopsy to confirm whether cancer is present. In a new study published in JAMA, researchers claim a targeted biopsy method is much more accurate in detecting high-risk prostate cancers than the standard biopsy technique.

“The standard method of prostate biopsy, also referred to as a core needle biopsy, involves a doctor removing samples of tissue from the prostate using a thin, hollow needle. The samples are then sent to a pathologist who views them under a microscope and assesses them for cell abnormalities that indicate cancer.

“But the research team, led by Dr. Mohammad Minhaj Siddiqui of the University of Maryland School of Medicine – who was a fellow at the National Institutes of Health at the time of study – says the technique used in their study involves a combination of ultrasound and magnetic resonance imaging (MRI), which they say can effectively differentiate high-risk prostate cancers from those that are low risk.

” ‘There is a concern that we overdiagnose and overtreat low-risk cancers that are unlikely to be terminal, and this technology enables us to make a more reliable diagnosis than the current standard practice,’ says Dr. Siddiqui.”


Pancreatic Cancer Biopsies Do Not Cause Cancer to Spread

The gist: New research shows that pancreatic cancer biopsies improve outcomes and do not cause cancer to spread, contrary to some beliefs. The researchers tested a biopsy technique known as fine needle aspiration. Because that technique is used in other cancer types, the researchers say their results likely apply to more than just pancreatic cancer patients.

“A study of more than 2,000 patients by researchers at Mayo Clinic’s campus in Jacksonville, Florida, has dispelled the myth that cancer biopsies cause cancer to spread. In the Jan. 9 online issue of Gut, they show that patients who received a biopsy had a better outcome and longer survival than patients who did not have a biopsy.

“The researchers studied pancreatic cancer, but the findings likely apply to other cancers because diagnostic technique used in this study——is commonly used across tumor types, says the study’s senior investigator and gastroenterologist Michael Wallace, M.D., M.P.H., professor of medicine.

“Fine needle aspiration is a minimally invasive technique that uses a thin and hollow needle to extract a few cells from a tumor mass. A long-held belief by a number of patients and even some physicians has been that a biopsy can cause some cancer cells to spread.”


Urine Test for PCA3 Helps Patients Avoid Unnecessary Prostate Biopsies

“In a study reported in the Journal of Clinical Oncology, Wei et al found that use of urinary prostate cancer antigen 3 (PCA3) measurement could improve avoidance of repeat prostate biopsy and detection of prostate cancer in biopsy-naive patients.

“This National Cancer Institute study involved 859 men (mean age, 62 years) from 11 centers scheduled for diagnostic prostate biopsy between December 2009 and June 2011.

“PCA3 scores were reported as a ratio of urinary PCA3 mRNA to prostate-specific antigen mRNA. Among men presenting for initial prostate biopsy, PCA score > 60 had a sensitivity of 42%, specificity of 91%, and positive predictive value of 80% (95% confidence interval [CI] = 72%–86%) for detection of any cancer. Among men presenting for repeat biopsy, PCA score < 20 had negative predictive value of 88% (95% CI = 81%–93%), with sensitivity and specificity of 76% and 52% for absence of cancer…

“The investigators concluded: ‘These data independently support the role of PCA3 in reducing the burden of prostate biopsies among men undergoing a repeat prostate biopsy. For biopsy-naive patients, a high PCA3 score (>60) significantly increases the probability that an initial prostate biopsy will identify cancer.’ “


Testing for Drug-Resistant Bacteria before Prostate Biopsy Can Reduce Infections

“Some infections after prostate biopsy due to drug-resistant Escherichia coli can be thwarted by simple rectal swab cultures prior to the procedure. The cultures test for antibiotic-resistant E. coli, and the findings are used to direct the selection of antimicrobial prophylaxis used for the procedure, according to Rhode Island Hospital researchers. The study was recently published in Urology.

“For patients undergoing transrectal ultrasound (TRUS)-guided biopsies, Ciprofloxacin may not be the best prophylactic option to use for patients colonized with Ciprofloxacin-resistant E. coli.

” ‘Aware of the increasing number of resistant strains of E. coli, our urologic physicians sought to decrease the number of post-biopsy infections and readmissions by conducting cultures on patient fecal samples to identify antibiotic-resistant strains before the biopsy is done, and the results were used to make the best antibiotic choice for prophylaxis,’ said Leonard Mermel, D.O., medical director of the department of epidemiology and infection control at Rhode Island Hospital. ‘As effective as biopsies are for diagnosing cancer, they do carry some risk of infection.’ “


Biopsies More Costly, Less Effective in Lung Cancer Diagnosis

“Biopsies were identified as the most costly tests in lung cancer diagnosis, with negative biopsies accounting for 43.1% of total diagnostic costs, according to study findings.

“Researchers noted that decreasing biopsy referrals by providing better risk stratification could reduce health care costs and improve patient outcome.

“In the retrospective cohort study, Tasneem Lokhandwala, PhD, MS, a data analyst at Xcenda, and colleagues reviewed data collected from the 5% Medicare random national sample from 2009 to 2011…

“ ‘This study provides a baseline of current costs for the lung cancer diagnostic workup prior to the introduction of major lung cancer screening programs. Biopsy costs comprise a significant proportion of the overall cost of diagnosing lung cancer,’ Lokhandwala said in a press release. ‘These results suggest that since NCCN guidelines are not being followed, there is a need to develop more precise risk stratification tools to better identify patients who require lung biopsies. Reducing the number of patients who are referred for lung biopsies has the potential to decrease Medicare costs and ultimately improve patient outcomes.’ ”


ctDNA 'Liquid Biopsy' Could Revolutionize Cancer Care

“Bits of tumor cell somatic DNA shed into the circulation or released when cells die can now be detected and counted, thanks to advances in gene sequencing. This circulating tumor DNA (ctDNA) is derived from somatic mutations that occur in the tumor during an individual’s life, unlike hereditary mutations that are present in every cell in the body, so ctDNA is a specific cancer biomarker that can be detected, measured, and tracked.

“Monitoring ctDNA is expected to provide clinicians with faster, cheaper, less invasive ways to assess cancer patients’ clinical status and response to therapy. ctDNA assay for multiple genes via next-generation sequencing (NGS) might become a ‘liquid biopsy’ alternative to invasive tissue biopsy, experts told Medscape Medical News.

“However, they also cautioned that rigorous testing of this concept is needed before the test can be used in practice, saying: ‘for now, we would counsel clinicians not to jump the gun on this.’ “


PCA3 May Have Role Predicting Prostate Biopsy Outcome

“The use of a prostate cancer antigen 3 (PCA3) urine test could help men avoid undergoing unnecessary repeat biopsies, and could help physicians predict which men undergoing initial biopsy will be positive for cancer.

“John T. Wei, MD, of the University of Michigan, and colleagues published the results of the National Cancer Institute Early Detection Research Network validation of PCA3 trial in the Journal of Clinical Oncology.

“According to Wei, how physicians decide to send a patient for prostate biopsy is continuing to evolve. Although in the past, an abnormal PSA test resulted in an order for a biopsy, the discovery and validation of new biomarkers is changing that precedent.

“ ‘Prostate cancer tests such as the PCA3, an FDA approved, commercially available urine assay for prostate cancer, are allowing doctors to more accurately determine if a man has prostate cancer prior to a biopsy,’ Wei told Cancer Network. ‘Based on our findings, using PCA3, many fewer men will need to undergo a repeat prostate biopsy. On the other hand, PCA3 may also indicate an elevated risk of prostate cancer in other men, prompting them to undergo a prostate biopsy when its needed.’

“In the study, Wei and colleagues evaluated 859 men scheduled for diagnostic prostate biopsy between 2009 and 2011. The researchers evaluated whether the PCA3 urine test had a high positive predictive value at initial biopsy and a high negative predictive value at repeat biopsy.”


New Hope for Potential Prostate Cancer Patients

“The latest advancement in prostate cancer detection is magnetic resonance imaging and ultrasound fusion-guided biopsy, which offers benefits for both patient and physician.

“The only place in the Southeast offering the MRI-US image fusion technique is at the University of Alabama at Birmingham Program for Personalized Prostate Cancer Care.

“It is estimated that 2014 will see more than 240,000 new cases of prostate cancer, and more than 29,000 deaths from the disease, according to the National Cancer Institute.

“Jeffrey Nix, M.D., along with colleague Soroush Rais-Bahrami, M.D., both assistant professors in the UAB Department of Urology, studied the MRI-US image fusion as fellows at the NCI. Nix and Rais-Bahrami are two of a select few urologists in the United States trained to utilize this technology; together they have five years’ experience using this approach.

“Nix and Rais-Bahrami say this new technology offers a ttargeted biopsy,’ which refers to direct tissue sampling of suspicious areas seen on MRI as opposed to the traditional method of random, systematic sampling that is essentially performed ‘blindly’ in different ‘ZIP code’ regions of the prostate.”


MDxHealth's ConfirmMDx Genes Identify Prostate Cancer Aggressiveness in Diagnostic Biopsies

The gist: Earlier this year, we posted about a new test that could reduce the need for multiple biopsies to accurately diagnose men with prostate cancer. Now, the company that makes the test, called ConfirmMDx, reports that the results of the test for a given patient strongly correlate with already-established measurements, such as Gleason Score (GS). This supports the use of the test to help diagnose and determine the severity of prostate cancer.

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced positive data from an important study confirming the ability of the ConfirmMDx® genes to identify prostate cancer (PCa) aggressiveness in diagnostic biopsies. The data, presented at the European Association of Urology, Section Urological Research (ESUR) meeting in Glasgow, UK (October 9-11, 2014), confirmed that the epigenetic profile of ConfirmMDx genes generated by the test is strongly correlated with established risk stratification metrics, such as Gleason Score (GS) and the NCCN (National Comprehensive Cancer Network) risk categories.

” ‘These data demonstrate that ConfirmMDx for Prostate Cancer not only provides important diagnostic information to help guide the decision on repeat biopsy, but that the genes may also deliver significant prognostic value, potentially determining whether a man has an aggressive or non-aggressive form of prostate cancer,’ noted Sandra M. Gaston PhD, Director of Urological Research at New England Baptist Hospital and Director of the Molecular Biomarkers Research Laboratory in the Department of Pathology and Laboratory Medicine at Tufts Medical Center in Boston Massachusetts. ‘This study suggests that the epigenetic markers used in the ConfirmMDx test could have an expanded role in stratifying prostate biopsy patients by providing information that cannot be obtained from the histological examination of the tissue. The current ConfirmMDx test is highly sensitive for DNA hypermethylation of GSTP1, APC and RASSF1 in the tissue surrounding a prostate cancer. For men who have a histological diagnosis of “no cancer,” a negative result with the current ConfirmMDx test predicts that a subsequent biopsy will also be negative, identifying the majority of men who may avoid repeat biopsy. In this study, we found that hypermethylation of these markers is more intense in the tissue surrounding high grade prostate cancer potentially providing additional insights into the clinical significance of a potential undetected prostate cancer on methylation-positive patients.’ “